FDA.report

510(k) K240003

Device
Velmeni for Dentists (V4D)
Applicant
Velmeni, Inc.
510(k) number
K240003
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-30
Date received
2024-01-02
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Mini Suri
Address
333 W. Maude Ave. , Suite 207 Sunnyvale CA US 94085 94085

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00860010893203Velmeni for DentistsVelmeni Inc.2024-12-11

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